ENT FiberLase CO2 Study

This study is intended to collect data regarding treatment with a new flexible fiber used to transmit laser emitted from a Carbon dioxide (CO2) laser to the transoral region. This study will include a single treatment that is performed transorally (through the mouth) for oral or laryngeal indications in the field of Ear, Nose and Throate (ENT).

Study Overview

• Status: Completed
• Conditions: Laryngeal Diseases; Pharyngeal Diseases
• Intervention / Treatment: Device: CO2 laser

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Yvoir, Belgium, 5530
    • University Hospital of Mont-Godinne
• Italy
  • Cesena, Italy
    • Bufalini Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. General good health allowing patient to undergo general anaesthesia or heavy sedation according to the specific procedure.
2. Adult
3. Able and willing to comply with all visit, treatment and evaluation schedule and requirements
4. Able to understand and provide written Informed Consent
5. Disease which requires tissue ablation for treatment

Exclusion Criteria:

1. Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to each treatment (as per the patient's physician discretion);
2. Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process
3. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
4. Any condition which, in the Physician's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	Device: CO2 laser; Ablation and coagulation of soft tissue; Other Names: Acupulse WG CO2 Laser; Fiberlase Flexible Fiber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to complete procedure with the study device	The number of interventions that were completed using the AcuPulse WG and FiberLase CO2 Fiber for the intended indication, without the need to revert to other means	Immediate - during intervention
Complications (bleeding, perforation, damage to non target tissue)	Number of subjects with Adverse Events as a Measure of Safety	During intervention and up to 6 weeks following the procedure

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: January 9, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Pharyngeal Diseases
• Other Study ID Numbers: LUM-SBUSUR-ACF-09-01